Related Manuals for MEDAP FINA AIR B 800
Summary of Contents for MEDAP FINA AIR B 800
- Page 1 OPERATING INSTRUCTIONS MEDAP TAPPING UNIT FINA AIR B 800, P 350, D 150, T 50 GA1GB.M20120.0...
- Page 2 Subject to technical modification! Illustrations and technical specifications may vary slightly from those in these operating instructions as a result of ongoing product development. V01 2022-09 GA1GB.M20120.0...
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Page 3: Table Of Contents
1.5.4 Overview of the FINA AIR T 50 ....................13 Versions ..............................14 1.6.1 Versions of the FINA AIR B 800 ....................14 1.6.2 Versions of the FINA AIR P 350 ....................15 1.6.3 Versions of the FINA AIR D 150 ....................16 1.6.4... - Page 4 Additional function check for the FINA AIR T 50 ................ 35 Working with the product .......................... 35 4.2.1 Setting the vacuum for treatment (FINA AIR B 800 and P 350) ..........36 4.2.2 Setting the vacuum for treatment (FINA AIR D 150 and T 50) ........... 36 Taking the unit out of operation ......................
- Page 5 FINA AIR B 800 ............................47 9.2.1 Accessories FINA AIR B 800 ..................... 47 9.2.2 Complete unit FINA AIR B 800 ....................47 9.2.3 Consumables FINA AIR B 800 ....................48 9.2.4 Application sets FINA AIR B 800 ....................48 FINA AIR P 350 ............................
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Page 6: Introduction
Introduction Foreword Introduction Foreword Your facility has selected the leading-edge medical technology made by ATMOS. We sincerely appreciate the trust you have placed in us. How to use these operating instructions These operating instructions are provided to familiarise you with the features of this ATMOS product. -
Page 7: Definitions
Introduction Symbols used 1.2.3 Definitions 1.2.3.1 Design of safety notes Pictogram Descriptor Text The text for the safety note DANGER! describes the type of risk and Indicates a direct and immediate risk to how to avert it. persons which may be fatal or result in most serious injury. - Page 8 Introduction Symbols used Symbols Identification This device complies with the relevant requirements of the EU regulations. Manufacturer Date of manufacture Date of manufacture Country of manufacture Reference number Unique Device Identifier of a medical device Medical device Serial number Batch code This side up Fragile, handle with care Keep dry...
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Page 9: Udi Code
Introduction Disposal Symbols Identification Humidity limitation Atmospheric pressure limitation Material designation for PA (polyamide) plastic Tab. 3: Symbols 1.3.1 UDI code UDI-DI: Identification of the manufacturer and the device (01) Batch code (10) Date of manufacture (11) Serial number (21) Tab. -
Page 10: Overview
Introduction Overview Overview 1.5.1 Overview of FINA AIR B 800 Fig. 1: Overview of FINA AIR B 800 1 Housing 7 Mechanical overflow protection 2 Shut-off valve 8 Bacterial filter housing 3 NIST connection 9 Control valve 4 Vacuum connection tube... -
Page 11: Overview Of The Fina Air P 350
Introduction Overview 1.5.2 Overview of the FINA AIR P 350 Fig. 2: Overview of the FINA AIR P 350 1 Housing 7 Tube connector of mechanical overflow protection 2 Shut-off valve 8 Mechanical overflow protection 3 NIST connection 9 Bacterial filter housing 4 Tube connector 10 Control valve 5 Vacuum connection tube... -
Page 12: Overview Of Fina Air D 150
Introduction Overview 1.5.3 Overview of FINA AIR D 150 Fig. 3: Overview of FINA AIR D 150 Vacuum gauge 8 Tube adapter mechanical overflow protection Housing 3 NIST connection 9 Mechanical overflow protection 4 Tube connector 10 Control valve 5 Vacuum connection tube 11 Bacterial filter housing 6 Hydrophobic bacterial and viral filter 12 Pressure-relief valve... -
Page 13: Overview Of The Fina Air T 50
Introduction Overview 1.5.4 Overview of the FINA AIR T 50 Fig. 4: Overview of the FINA AIR T 50 Vacuum gauge 7 Tube adapter mechanical overflow protection Housing 3 Tube connector 8 Mechanical overflow protection 4 Silicone vacuum tube (intermediate tube A) 9 Control valve 5 Hydrophobic bacterial and viral filter 10 Bacterial filter housing... -
Page 14: Versions
Introduction Versions Versions 1.6.1 Versions of the FINA AIR B 800 1 1 0 0 1 1 3 3 1 1 2 2 1 1 1 1 Fig. 5: Overview of FINA AIR B 800 versions Version A 8 Locking lever... -
Page 15: Versions Of The Fina Air P 350
Introduction Versions 1.6.2 Versions of the FINA AIR P 350 1 1 0 0 Fig. 6: Overview of the FINA AIR P 350 versions Version A 5 NIST nipple Tapping unit with integrated gas pin 6 NIST screw connection 2 Gas pin 7 Connection tube Locking lever 3 Terminal unit... -
Page 16: Versions Of The Fina Air D 150
Introduction Versions 1.6.3 Versions of the FINA AIR D 150 Fig. 7: Overview of FINA AIR D 150 variants Version A 5 Rail clamp Tapping unit with integrated gas pin 6 Locking lever 2 Plug 7 NIST nipple NIST screw connection 3 Terminal unit Version B Connection tube... -
Page 17: Versions Of The Fina Air T 50
Introduction Basic requirements 1.6.4 Versions of the FINA AIR T 50 Fig. 8: Overview of the FINA AIR T 50 versions Version A 5 Rail clamp Tapping unit with integrated gas pin 6 Locking lever 2 Plug 7 NIST nipple NIST screw connection 3 Terminal unit Version B... -
Page 18: Applicable Standards
Product Name: FINA AIR Main function: Only applies to FINA AIR B 800 and FINA AIR P 350: Aspiration of secretion, blood, serous fluids, vomiting and rinsing fluids along with any contained particles Only applies to FINA AIR D 150 and FINA AIR T 50:... - Page 19 The application site is the clinical environment and doctor’s practices which have a central compressed air supply system. Application by doctors, medically trained staff. Criteria for patient Only applies to FINA AIR B 800: selection: All patients who require aspiration Only applies to FINA AIR P 350:...
- Page 20 Introduction Basic requirements Medical contra-indications: Only applies to FINA AIR B 800: • Vacuum Extraction • Smoke Evacuation • For drainages in the low vacuum range (e.g. thoracic and wound drainage). Use in combination with disposable thoracic drainage systems with integrated vacuum regulation is excepted from this restriction.
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Page 21: Versions
Version C: Tapping unit for screw mount with NIST connection (FINA AIR B 800 only): • FINA AIR B 800 is designed for direct screw mounting onto mobile suction units (intensive care trolley / surgical trolley) and compact suction units (solo carrier frame) and is supplied with compressed air from a terminal unit via a NIST connection using a connection tube with a gas probe. -
Page 22: Hydrophobic Bacterial And Viral Filter
Introduction Basic requirements 1.7.5.1 Hydrophobic bacterial and viral filter The vacuum connection tube is used to connect the tapping unit and the septic fluid jar. In its function as overflow protection device, the hydrophobic bacterial and viral filter protects the product against the ingress of particles, fluid and foam. -
Page 23: Suction Tube
Introduction Basic requirements 1.7.9 Suction tube The suction tube acts as the connection between the septic fluid jar and the utensil. Technical specifications: • Shore hardness of 60 • Inner diameter of 6 to 8 mm • Length of 1.3 m to 3.0 m •... -
Page 24: Safety Notes
Danger to life! The product is not suitable for drainage and thoracic drainage. Use in combination with disposable thoracic drainage systems with integrated vacuum regulation is excepted from this restriction (FINA AIR B 800 only). DANGER! Danger to life! The product is not suitable for drainage or thoracic drainage (FINA AIR P 350 only). - Page 25 Safety notes Product safety notes DANGER! Risk of injury to mucous membranes! Endobronchial aspiration in paediatrics and neonatology requires particularly careful limitation of the vacuum. For the regular endobronchial aspiration in paediatrics and neonatology, ATMOS also offers paediatric versions with a higher level of setting convenience.
- Page 26 Furthermore, the filter must be exchanged if the vacuum displayed is above –0.3 bar / 30 kPa (FINA AIR B 800 and P 350), above 0.13 bar / 13 kPa (FINA AIR D 150), or above 0.05 bar / 5 kPa (FINA AIR T 50) when the vacuum controller is in the "max"...
- Page 27 Safety notes Product safety notes Report all serious incidents that have occurred in connection with this product to the manufacturer and your national competent authority. GA1GB.M20120.0...
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Page 28: Initial Operation
Initial operation Equipment inspection Initial operation Equipment inspection DANGER! Product inspection! Only product parts which are in perfect condition can ensure proper functioning of the product. The product parts will thus have to be carefully inspected before mounting. WARNING! Infection hazard! Contaminated components may endanger the health of staff and patients. -
Page 29: Inserting The Bacterial Filter Paper
Initial operation Mounting Fig. 10: Mounting the vacuum gauge (top view FINA AIR B 800 only) 3.2.2 Inserting the bacterial filter paper WARNING! Infection hazard! When in use, change the bacterial filter paper every day. Dispose of used bacterial filter papers in compliance with hygiene guidelines. -
Page 30: Connection To The Terminal Unit
Initial operation Mounting 3.2.3 Connection to the terminal unit 3.2.3.1 General NOTE Please refer to the manufacturer’s instructions for the particular terminal unit for information on connecting the gas probe to the terminal unit. 3.2.3.2 Version A Permanently connected to the housing ... -
Page 31: Version C (Fina Air B 800 Only)
Mounting 3.2.3.4 Version C (FINA AIR B 800 only) The tapping unit for screw connection may be connected to a surgical trolley or the FINA equipment carrier for aspiration set carrier frame solo. The carrier frame is used to show the assembly. -
Page 32: Assembly Of The Septic Fluid Jar And Accessories
Initial operation Mounting 3.2.4 Assembly of the septic fluid jar and accessories WARNING! Tensile forces! The connected accessories must not exert any mechanical forces which could adversely affect the secure fit of the product. WARNING! Tensile forces! Hold the basic unit with one hand when installing or removing accessories in order to compensate for the tensile forces which are created. - Page 33 Initial operation Mounting Connection of the hydrophobic bacterial and viral filter The connection tubes (1) and (2) are plugged onto the tube connectors of the hydrophobic bacterial and viral filter (3). Check the flow direction of the bacterial and viral filter.
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Page 34: Operation
All versions: • The product has been properly cleaned and neither residue nor contamination are present. • The regulating valve can be easily turned. The shut-off valve is functioning (FINA AIR B 800 and P 350 only). • The overflow protection device and the hydrophobic bacterial and viral filter are mounted, fully functional and no residue is trapped in it. -
Page 35: Additional Function Check For The Fina Air T 50
Operation Working with the product 4.1.1 Additional function check for the FINA AIR T 50 Fig. 19: Pressure-relief valve of the tapping unit • The pressure-relief valve (1) of the tapping unit is not clogged. • The pressure-relief valve (silicone washer) of the tapping unit is pressed tight and centred on the sealing edge of the pressure-relief valve seat. -
Page 36: Setting The Vacuum For Treatment (Fina Air B 800 And P 350)
Operation Working with the product 4.2.1 Setting the vacuum for treatment (FINA AIR B 800 and P 350) Open the shut-off valve (1) completely for operation. For this purpose, turn the valve by 90° so that it is in line with the gas supply. -
Page 37: Taking The Unit Out Of Operation
Taking the unit out of operation Completing the aspiration process Taking the unit out of operation Completing the aspiration process DANGER! Infection hazard! Any and all of the components in the septic fluid jar might be contaminated. Always wear gloves when emptying the septic fluid jar and be absolutely sure to follow the hygiene rules. -
Page 38: Cleaning And Disinfection
Cleaning and disinfection General Cleaning and disinfection General The product must be wipe or spray disinfected after every use. DANGER! Risk due to incorrect use of detergents and disinfectants! It is strictly advised to observe the manufacturer’s instructions regarding how to use the detergents and disinfectants as well as to observe the valid hospital hygiene rules. -
Page 39: Cleaning
Cleaning and disinfection Cleaning Cleaning 6.2.1 General NOTE Use only all-purpose cleaners which are slightly alkaline (soap solutions) and contain surfactants and phosphates as the active cleaning agents. In the event of heavily contaminated surfaces, use concentrated all-purpose detergent. WARNING! Improper cleaning can cause property damage! Residues of physiological saline solutions (e.g. -
Page 40: Suitable Disinfectants
Cleaning and disinfection Disinfection CAUTION! Material damage due to excessive exposure times! Exceeding the specified exposure time of the disinfectant may damage the surfaces. Observe the exposure time specified by the disinfectant manufacturer. 6.3.2 Suitable disinfectants Only surface disinfectants based on the following combinations of active ingredients may be used for disinfection: •... -
Page 41: Special Safety Notes
Cleaning and disinfection Special safety notes Components Wipe, spray disinfection Trolley Catheter holder Bacterial filter paper When in use, must be replaced daily. 1 After exposure (as prescribed in the manufacturer's instructions), remove disinfectant residues from the components using a moist cloth and dry them afterwards. Special safety notes DANGER! Health hazard! -
Page 42: Maintenance
Maintenance General Maintenance General Maintenance, repairs and periodic tests may only be carried out by persons who have the appropriate technical knowledge and are familiar with the product. To carry out these measures, the person must have the necessary test devices and original spare parts. ATMOS recommends: Work should be carried out by an authorised ATMOS service partner. -
Page 43: Repairs
Maintenance Repairs Defect Source of malfunction Troubleshooting Shut-off valve is defective Contact Technical Service (FINA AIR B 800 and P 350 only) Central supply system failure Gas probe connection is loose Vacuum gauge is defective Control valve is defective Gas-jet pump is defective(... -
Page 44: Spare Parts
Vacuum gauge for drainage (FINA AIR D 150) HM57522104 Vacuum gauge for drainage 0–5 kPa ( FINA AIR T 50) HM57525004 Bacterial filter set FINA AIR B 800 / P 350 / D 150 HM57525001 Bacterial filter set FINA AIR T 50 HM57525013... -
Page 45: Technical Specifications
Technical specifications FINA AIR B 800 Technical specifications Nominal pressure, gas supply 500 kPa ± 10% Pressure relief valve on patient side opens at approx. 0.05 kPa** Vacuum gauge Accuracy class 2.5 Environmental: Transport/storage • Temperature range -15...+50 °C • Air humidity without condensation 10...95%... -
Page 46: Fina Air D 150
Technical specifications FINA AIR D 150 FINA AIR D 150 Vacuum control range at 500 kPa 0 to -13 kPa* Flow rate* (freeflow) at 500 KPa at least 8 l/min Excess pressure on patient side maximum 0,6 kPa* Air consumption gas-jet pump approx. -
Page 47: Approved Accessories
ATMOS suction liner 2 l, 100 pieces 401.0102.0 ATMOS suction liner 1 l, 100 pieces HM57522049 Vacuum shift HM57524538 Bowl, diameter 20 cm AIR connection tube with NIST screw connector (see MEDAP tube list) Tab. 8: Accessories 9.2.2 Complete unit FINA AIR B 800... -
Page 48: Consumables Fina Air B 800
Fingertip Tab. 10: Consumables 9.2.4 Application sets FINA AIR B 800 HM57523330 Aspiration set for equipment rail / 1 l HM57525810 Aspiration set for equipment rail / 1 l/ ATMOS HM57525811 Aspiration set for equipment rail / 2 l/ ATMOS... -
Page 49: Consumables Fina Air P 350
ATMOS suction liner 3 l, 70 pieces 401.0202.0 ATMOS suction liner 2 l, 100 pieces 401.0102.0 ATMOS suction liner 1 l, 100 pieces HM57508021 Tube holder AIR connection tube with NIST screw connector (see MEDAP tube list) Tab. 12: Accessories 9.3.2 Consumables FINA AIR P 350 HM57505045 Bacterial filter paper (100 pieces) HM57500630 Hydrophobic bacterial and viral filter 006.0009.0... -
Page 50: Consumables Fina Air D 150
401.0302.0 ATMOS suction liner 3 l, 70 pieces 401.0202.0 ATMOS suction liner 2 l, 100 pieces 401.0102.0 ATMOS suction liner 1 l, 100 pieces AIR connection tube with NIST screw connector (see MEDAP tube list) Tab. 15: Accessories 9.4.2 Consumables FINA AIR D 150 HM57500630 Hydrophobic bacterial and viral filter HM57505045 Bacterial filter paper (100 pieces) 006.0009.0... - Page 51 Notes...
- Page 52 Hersteller: ATMOS MedizinTechnik GmbH & Co. KG Ludwig-Kegel-Str. 16 79853 Lenzkirch DEUTSCHLAND Telefon: +49 7653 689-0 www.atmosmed.com...
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